6th Qserve MedTech Conference - Digital Health
Taking place from 10 to 12 November 2026 in Amsterdam, the 6th Qserve MedTech Conference brings together the brightest minds in Digital Health to help you stay ahead in an ever-evolving landscape.
Weβre pleased to announce the return of the Qserve MedTech Conference, a must-attend event for MedTech professionals navigating an evolving global regulatory landscape.
π Amsterdam, The Netherlands
π 10-12 November, 2026
ππ‘ππ ππ¨ ππ±π©πππ of Digital Health: A two-day conference on ππβππ ππ¨π―ππ¦πππ«, ππππ, featuring plenary sessions, expert panels, and multiple parallel tracks with in-depth discussions on key regulatory and industry topics.
By combining regulatory insight, hands-on experience, and real-world industry challenges, the Qserve MedTech Conference offers valuable opportunities to deepen your expertise and connect with others. Further details on the program, speakers, and key topics will be shared in the coming months.
We look forward to welcoming you to Amsterdam for the #QserveMedTechConference. Sign up now and check the schedule!
The Digital Health Track consists of 5 sessions divided over two days. On day 1 there will be two sessions covering topics like AI compliance and the Digital Omnibus. On day 2 there will be three different sessions, including themes like Software & Risk Management, Cybersecurity and other Digital Health Regulations.
Not only will our own Qserve experts take the stage to tell you about these topics in-depth, Notified Bodies and relevant Industry Speakers will join these sessions. Stay tuned for more information on the external speakers.
Each session lasts 1,5 hour. Please make sure to be at the location before the session starts.
The Digital Health Track consists of 5 sessions divided over two days. On day 1 there will be two sessions covering topics like AI compliance and the Digital Omnibus. On day 2 there will be three different sessions, including themes like Software & Risk Management, Cybersecurity and other Digital Health Regulations.
Not only will our own Qserve experts take the stage to tell you about these topics in-depth, Notified Bodies and relevant Industry Speakers will join these sessions. Stay tuned for more information on the external speakers.
Each session lasts 1,5 hour. Please make sure to be at the location before the session starts.
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Read more about our sessions
Session 1 - AI in Medical Devices
Artificial intelligence is transforming medical devices, but regulatory compliance remains a key challenge. This session provides a clear overview of how AI-driven devices are regulated under MDR, IVDR, and upcoming guidance. You will explore how AI impacts clinical evaluation, risk management, and submission documentation, including unique considerations for adaptive algorithms and software updates.
Through practical examples, you will learn how to ensure compliance throughout the lifecycle, anticipate regulatory questions, and document AI components effectively in submissions.
Session 2 - Digital Omnibus
Digital technologies are transforming medical devices, diagnostics, and healthcare systems. This session provides a practical overview of regulatory, technical, and clinical considerations for digital health products. You will learn about interoperability, cloud-based solutions, data exchange, and integration into health ecosystems.
The omnibuses from the AI Act, Digital health, MDR and IVDR 2.0 and the influences on the AI Medical devices will be discussed.
Session 3 - Software, AI & Risk Management
Software is at the heart of modern medical devices, but it introduces specific risks and regulatory requirements. This session explores software lifecycle management, risk management integration, and compliance with IEC 62304 and ISO 14971. You will gain practical guidance on documenting software development, validation, and risk mitigation while maintaining regulatory compliance.
Through examples and interactive discussion, participants will see how to implement a robust software risk management framework that meets both technical and regulatory standards.
Session 4 - Cybersecurity in Medical Devices
Cybersecurity is a core regulatory requirement for modern medical devices. This session provides a practical overview of how to implement cybersecurity across the product lifecycle, aligned with MDR, IVDR, and international guidance.
You will learn how to identify vulnerabilities, manage threats, and ensure secure design, while maintaining compliance. The session also covers post-market surveillance, incident handling, and expectations from regulators and notified bodies.
Session 5 - Navigating Europe
Europeβs digital regulatory landscape is rapidly evolving, with the European Health Data Space (EHDS), GDPR, and other digital health regulations reshaping how medical device and IVD companies manage and use data.
This session provides a clear, practical overview of how these frameworks interact and what they mean for your organization. You will learn how to ensure compliance with data protection requirements while leveraging opportunities for innovation, including secondary use of health data and real-world evidence generation.
General and Startups
Through 5 sessions, gain practical insights into regulatory strategy, funding and scaling challenges tailored to emerging MedTech companies and innovators.
In-Vitro-Diagnostics
In two focused sessions, understand the latest developments in IVDR compliance, from performance evaluation to lessons learned from CDx submissions.
Global Registrations
Over 3 sessions, learn how to efficiently navigate international regulatory pathways and accelerate market access across key global regions.
Clinical
In 5 sessions, discover best practices for clinical strategy, PMCF data collection, PMCF surveys with real-world data and more.
Demonstrations
Across 3 live demonstrations, experience Qserve Learn, Qserve InSight and AI Clinical in action, showcasing solutions to streamline training, regulatory intelligence, and clinical processes.
Choose Your Conference Experience
Pre-Conference Workshop Ticket
Join our hands-on pre-conference workshops on 10 November 2026 and gain practical insights through focused sessions designed to prepare you for the latest MedTech regulatory challenges.
Conference Ticket
Attend the two-day conference on 11 and 12 November 2026 to access expert-led sessions, industry insights, and valuable networking with MedTech professionals.
Full Conference Ticket
Get the complete experience with access to both the pre-conference workshops on 10 November and the full two-day conference on 11 and 12 November 2026.
We offer group tickets and special offers, contact training@qservegroup.com for more information.
We offer group tickets and special offers, contact training@qservegroup.com for more information.